Loading clinical trials...

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III

NCT01827046•Johns Hopkins University

Summary

A phase III, randomized, case-controlled, open-label, 500-subject clinical trial of minimally invasive surgery plus rt-PA in the treatment of intracerebral hemorrhage (ICH).

Detailed Description

Primary Objectives: Efficacy: Demonstrate that minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) for three days improves functional outcome by a 12% increase in the modified Rankin Scale (mRS) score 0-3 compared to medically treated subjects assessed at 365 days. Secondary Objective: Demonstrate that the end of treatment volume and percent of ICH reduction from MIS+rt-PA is related to improved functional outcome, as compared to medically treated subjects. Safety: Demonstrate that early use of MIS+rt-PA for three days is safe for the treatment of ICH relative to rates of mortality, rebleeding, and infection in the medically treated subject at 30 days.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Spontaneous supratentorial ICH ≥ 30 mL diagnosed using radiographic imaging (computerized tomography (CT), computerized tomography angiography (CTA), etc.), with a Glasgow Coma Scale (GCS) ≤ 14 or a NIHSS ≥ 6.
•Stability CT scan done at least 6 hours after diagnostic CT showing clot stability (growth \< 5 mL as measured by ABC/2 method).
•Symptoms less than 24 hours prior to diagnostic CT (dCT) scan (an unknown time of onset is exclusionary).
•Ability to randomize between 12 and 72 hours after dCT.
•Systolic Blood Pressure (SBP) \< 180 mmHg sustained for six hours recorded closest to the time of randomization.
•Historical Rankin score of 0 or 1.
•Age ≥ 18 and older.

Exclusion Criteria

•Infratentorial hemorrhage.
•Intraventricular hemorrhage (IVH) requiring treatment for IVH-related (casting) mass effect or shift due to trapped ventricle. External ventricular drain (EVD) to treat intracranial pressure (ICP) is allowed.
•Thalamic bleeds with apparent midbrain extension with third nerve palsy or dilated and non-reactive pupils. Other (supranuclear) gaze abnormalities are not exclusions. Note: Patients with a posterior fossa ICH or cerebellar hematomas are ineligible.
•Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
•Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease, hemorrhagic conversion of an ischemic infarct, recurrence of a recent (\< 1 year) hemorrhage diagnosed with radiographic imaging.
•Patients with unstable mass or evolving intracranial compartment syndrome.
•Platelet count \< 100,000; international normalized ratio (INR) \> 1.4.
•Any irreversible coagulopathy or known clotting disorder.
•Inability to sustain INR ≤ 1.4 using short- and long-active procoagulants (such as but not limited to NovoSeven, Fresh Frozen Plasma (FFP), and/or vitamin K).
•Subjects requiring long-term anti-coagulation are excluded. Reversal of anti-coagulation is permitted for medically stable patients who can realistically tolerate the short term risk of reversal. Patient must not require Coumadin (anticoagulation) during the first 30 days, and normalized coagulation parameters must be demonstrated, monitored closely and maintained during the period of brain instrumentation.
+15 more criteria

Locations (84)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Good Samaritan Hospital

Phoenix, Arizona, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Scripps Health

La Jolla, California, United States

University of California, Los Angeles

Los Angeles, California, United States

University of California, San Diego

San Diego, California, United States

Stanford University

Stanford, California, United States

Hartford Hospital

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Key Dates

Start Date

December 30, 2013

Primary Completion Date

September 1, 2018

Completion Date

September 1, 2018

Last Updated

September 27, 2019

Enrollment

499

ACTUAL participants

Conditions

Intracerebral Hemorrhage

Interventions

rt-PA

DRUG

Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

NCT07458880

Intracerebral Hemorrhage

View study

RECRUITINGNA

Evaluating a Prototype CT Scan for ICH Evacuation

NCT07455201

Intracerebral Hemorrhage

View study

RECRUITING

Hemodynamic ABI Monitor

NCT06725108

Traumatic Brain Injury (TBI)

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 27, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Minimally Invasive Surgery Plus Rt-PA for ICH Evacuation Phase III

Inclusion Criteria

Exclusion Criteria

Triple Antihypertensive Medication After Intracerebral Hemorrhage for Blood Pressure Control

Evaluating a Prototype CT Scan for ICH Evacuation

Hemodynamic ABI Monitor

Short-term And Longer-term Cognitive Impact Of Neurochecks

Dutch Intracerebral Hemorrhage Surgery Trial

Cerebrovascular Disease: Quality of Life (CODE: QoL)